Vaskedesinfektorer – Del 7: Krav og prøvninger til ... · Annex ZA’, the user should always check that any referenced document has not been superseded and that ... EN ISO 15883-1:2009

Dansk standard

DS/EN ISO 15883-7:2016

1. udgave 2016-04-19

Vaskedesinfektorer – Del 7: Krav og

prøvninger til vaskedesinfektorer med kemisk desinfektion til ikke-invasivt, ikke-kritisk termolabilt medicinsk udstyr og udstyr til sundhedspleje

Washer-disinfectors – Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)

DS-publikationstyper Dansk Standard udgiver forskellige publikationstyper. Typen på denne publikation fremgår af forsiden. Der kan være tale om: Dansk standard

• standard, der er udarbejdet på nationalt niveau, eller som er baseret på et andet lands nationale standard, eller • standard, der er udarbejdet på internationalt og/eller europæisk niveau, og som har fået status som dansk standard

DS-information • publikation, der er udarbejdet på nationalt niveau, og som ikke har opnået status som standard, eller • publikation, der er udarbejdet på internationalt og/eller europæisk niveau, og som ikke har fået status som standard, fx en

teknisk rapport, eller • europæisk præstandard DS-håndbog • samling af standarder, eventuelt suppleret med informativt materiale

DS-hæfte • publikation med informativt materiale

Til disse publikationstyper kan endvidere udgives

• tillæg og rettelsesblade DS-publikationsform Publikationstyperne udgives i forskellig form som henholdsvis

• fuldtekstpublikation (publikationen er trykt i sin helhed) • godkendelsesblad (publikationen leveres i kopi med et trykt DS-omslag) • elektronisk (publikationen leveres på et elektronisk medie)

DS-betegnelse Alle DS-publikationers betegnelse begynder med DS efterfulgt af et eller flere præfikser og et nr., fx DS 383, DS/EN 5414 osv. Hvis der efter nr. er angivet et A eller Cor, betyder det, enten at det er et tillæg eller et rettelsesblad til hovedstandarden, eller at det er indført i hovedstandarden. DS-betegnelse angives på forsiden. Overensstemmelse med anden publikation: Overensstemmelse kan enten være IDT, EQV, NEQ eller MOD

• IDT: Når publikationen er identisk med en given publikation. • EQV: Når publikationen teknisk er i overensstemmelse med en given publikation, men

præsentationen er ændret. • NEQ: Når publikationen teknisk eller præsentationsmæssigt ikke er i overensstemmelse med en

given standard, men udarbejdet på baggrund af denne. • MOD: Når publikationen er modificeret i forhold til en given publikation.

DS/EN ISO 15883-7:2016 København DS projekt: M284820 ICS: 11.080.10 Første del af denne publikations betegnelse er: DS/EN ISO, hvilket betyder, at det er en international standard, der har status både som europæisk og dansk standard. Denne publikations overensstemmelse er: IDT med: ISO 15883-7:2016. IDT med: EN ISO 15883-7:2016. DS-publikationen er på engelsk.

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM

EN ISO 15883-7 March 2016

ICS 11.080.10 English Version Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016) Laveurs désinfecteurs - Partie 7: Exigences et essais pour les laveurs désinfecteurs utilisant la désinfection chimique pour les dispositifs médicaux et les équipements de soins thermosensibles non invasifs et non critiques (ISO 15883-7:2016)

Reinigungs-Desinfektionsgeräte - Teil 7: Anforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für nicht invasive, nicht kritische thermolabile Medizinprodukte und Zubehör im Gesundheitswesen (ISO 15883-7:2016) This European Standard was approved by CEN on 8 February 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION C O M I T É E U R O P É E N D E N O R M A L I S A T I O N E U R O P Ä I S C H E S K O M I T E E F Ü R N O R M U N G CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15883-7:2016 E

EN ISO 15883-7:2016 (E)

2

Contents Page

European foreword ....................................................................................................................................................... 3

Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered ...................................... 5

EN ISO 15883-7:2016 (E)

3

European foreword

This document (EN ISO 15883-7:2016) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” in collaboration with Technical Committee CEN/TC 102 “Sterilizers for medical purposes” the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2016, and conflicting national standards shall be withdrawn at the latest by September 2016.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.

The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, for any use of this standard ‘within the meaning of Annex ZA’, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art.

When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard as listed below.

NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply.

Table — Correlation between normative references and dated EN and ISO standards

Normative references as listed in Clause 2 of the ISO

standard

Equivalent dated standard

EN ISO

ISO 11737-1 EN ISO 11737-1:2006 + EN ISO 11737-1:2006/AC:2009

ISO 11737-1:2006 + ISO 11737-1:2006/Cor 1:2007

ISO 11737-2 EN ISO 11737-2:2009 ISO 11737-2:2009

ISO 15883-1 EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014

ISO 15883-1:2006 + ISO 15883-1:2006/Amd1:2014

ISO 15883-2 EN ISO 15883-2:2009 ISO 15883-2:2006

ISO 15883-3 EN ISO 15883-3:2009 ISO 15883-3:2006

ISO 15883-4 EN ISO 15883-4:2009 ISO 15883-4:2008

ISO 15883-6 EN ISO 15883-6:2015 ISO 15883-6:2011

ISO/TS 15883-5 CEN ISO/TS 15883-5:2005 ISO/TS 15883-5:2005

IEC 61010–2-040 EN 61010-2-040:2005 IEC 61010-2-040:2005

EN ISO 15883-7:2016 (E)

4

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 15883-7:2016 has been approved by CEN as EN ISO 15883-7:2016 without any modification.

EN ISO 15883-7:2016 (E)

5

Annex ZA (informative)

Relationship between this European Standard and the essential

requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered

This European Standard has been prepared under a Commission's standardization request M/023 concerning the development of European standards to medical devices to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [OJ L 169].

Once this standard is cited in the Official Journal of the European Union under that Directive, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding essential requirements of that Directive, and associated EFTA regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC, as amended by 2007/47/EC. This means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according to the wording of the corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.

NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword, replacing the references in the core text.

NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard.

Table ZA.1 — Correspondence between this European standard and Annex I of Directive 93/42/EEC [OJ L 169]

Essential Requirements of EU Directive 93/42/EEC

Clause(s)/subclause(s) of this European Standard

Remarks/Notes

7.2 9 In addition requirements of EN ISO 15883-1 apply. Reference to IEC 61010-2-040:2005, Clause 5 included in respect of packaging only

7.3 4.1.1, 4.1.4

7.4 WD is not designed to deal with such medical products

7.5 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.24.1

EN ISO 15883-7:2016 (E)

6



Remarks/Notes

7.6 4.1.1, 4.7.1

8.1 4.1.1, 4.3, 4.5, 4.7.2 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 4.3.1

9.1 4.1.1, 4.1.3, 5.1.1, 8 a) Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.1.9, 5.1.10, 5.6 and 5.28

9.2 4.1.1, 4.1.3, 5.1.1, 5.1.2 Including reference to IEC 61010-2-040:2005, 5.4.3 and 7.5

9.3 WDs are unlikely to be manufactured of or to contain flammable or explosive substances

10.1 Not likely to apply, see MEDDEV 2.1

11 Intended hazardous radiation is unlikely to be emitted by a WD

12.1 4.1.1



12.7.1 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1




EN ISO 15883-7:2016 (E)

7



Remarks/Notes

12.9 4.1.1

13.1 4.1.1


13.3 a), b), d) 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 9.1

13.3 i) 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.29

13.3 k) 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.3

13.3 I) 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 9.1

13.4 4.1.1 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 8.1 b)

13.6 a) Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 9.1

13.6 b) 8 f) Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 8.3

13.6 c) 4.1.4, 4.3.4 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 8.2 h)

13.6 d) 8 a), c), h) Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 6.1.3.2, 8.1 and 8.3 g)

13.6 q) 8 Including reference to EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, Clause 8

EN ISO 15883-7:2016 (E)

8

For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery, in accordance with Article 3 of Directive 93/42/EEC the following Table ZA.2 details the relevant essential requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus does not provide presumption of conformity for the machinery directive.

Table ZA.2 — Relevant Essential Health and Safety Requirements from Directive 2006/42/EC on machinery that are addressed by this European Standard

(according to Article 3 of amended Directive 93/42/EEC)

Essential Health and Safety Requirements (EHSRs) of

Directive 2006/42/EC

Clause(s)/sub-clause(s) of this European Standard

Qualifying remarks/Notes

1 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.3 and 5.2.4

1.1.2 4.1.1, 5.1.1, 5.1.2 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.1

1.1.3 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.1.1, 5.1.2, 5.2 and 5.3.2 a)

1.1.5 4.1.1 See in addition EN ISO 15883-1:2009, 9.2

1.1.6 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.12.3, 5.27.1 and 6.6.2

1.1.7 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2

1.2.1, 1st dash and 2nd dash 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.2, 5.2.4, 5.12.1, 5.20 and 5.22

1.2.2, 1st dash 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2, 5.12.3, 5.12.8 and 5.12.9

1.2.3 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1

1.2.4.1 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 and 5.19

EN ISO 15883-7:2016 (E)

9





1.2.5 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.18 and 5.19

1.2.6 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2 and 5.4.1.9

1.3.1 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 Including reference to EN 61010-2-040:2005, 7.3

1.3.2 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.1, 5.2.1 and 8.3 g)


1.3.4 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.1.6 and 5.2.1 Including reference to EN 61010-2-040:2005, Clause 7






EN ISO 15883-7:2016 (E)

10






1.5.4 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 and 8.3





1.5.9 4.1.1 See in addition EN ISO 15883-1:2009, 5.2.1

1.5.13 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 and 8.1 b) Including reference to EN 61010-2-040:2005, Clause 11

1.5.14 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 Including reference to EN 61010-2-040:2005, Clause 15

1.5.15 4.1.1, 5.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1


EN ISO 15883-7:2016 (E)

11





1.6.1 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.1.5 and 5.2.1

1.6.2 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.1.5 and 5.2.1

1.6.3 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 and 8.2 a) and b)

1.6.4 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 and 5.4.1.6

1.6.5 4.1.1, 4.5 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 4.2.1.1 and 5.1.10

1.7.1 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1, 5.10.2, 5.10.3 and 5.20 h)

1.7.2 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, 5.2.1 and 8 f)


1.7.4 4.1.1 See in addition EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014, Clause 7 and Clause 8

WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European standard is maintained in the list published in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union.

WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of this standard.

© ISO 2016

Washer-disinfectors —Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipmentLaveurs désinfecteurs —Partie 7: Exigences et essais pour les laveurs désinfecteurs utilisant la désinfection chimique pour les dispositifs médicaux et les équipements de soins thermosensibles non invasifs et non critiques

INTERNATIONAL STANDARD

ISO15883-7

First edition2016-02-01

Reference numberISO 15883-7:2016(E)

ISO 15883-7:2016(E)

ii © ISO 2016 – All rights reserved

COPYRIGHT PROTECTED DOCUMENT

© ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester.

ISO copyright officeCh. de Blandonnet 8 • CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 [email protected]

ISO 15883-7:2016(E)

Foreword ..........................................................................................................................................................................................................................................vIntroduction ................................................................................................................................................................................................................................vi1 Scope ................................................................................................................................................................................................................................. 12 Normative references ...................................................................................................................................................................................... 13 Termsanddefinitions ..................................................................................................................................................................................... 24 Performance requirements ....................................................................................................................................................................... 2

4.1 General ........................................................................................................................................................................................................... 24.2 Cleaning ......................................................................................................................................................................................................... 34.3 Disinfection ................................................................................................................................................................................................ 34.4 Final rinsing ............................................................................................................................................................................................... 54.5 Self-disinfection ..................................................................................................................................................................................... 54.6 Drying ............................................................................................................................................................................................................. 64.7 Water treatment equipment........................................................................................................................................................ 6

4.7.1 General...................................................................................................................................................................................... 64.7.2 Disinfection of water treatment equipment ............................................................................................. 64.7.3 Maintenance of piping ................................................................................................................................................. 7

5 Mechanical requirements ........................................................................................................................................................................... 75.1 Materials — Design, manufacture, and assembly ..................................................................................................... 75.2 Process verification ............................................................................................................................................................................. 7

6 Testing for conformity .................................................................................................................................................................................... 76.1 General ........................................................................................................................................................................................................... 76.2 Test load ........................................................................................................................................................................................................ 8

6.2.1 Loading with standard goods ............................................................................................................................... 86.2.2 Loading with special goods .................................................................................................................................... 8

6.3 Water used for rinsing following disinfection .............................................................................................................. 86.4 Load dryness ............................................................................................................................................................................................. 8

6.4.1 General...................................................................................................................................................................................... 86.4.2 Procedure ............................................................................................................................................................................... 86.4.3 Results ....................................................................................................................................................................................... 8

6.5 Thermometric tests ............................................................................................................................................................................ 86.5.1 General...................................................................................................................................................................................... 86.5.2 Load temperature test ................................................................................................................................................. 8

6.6 Chemical dosing tests ........................................................................................................................................................................ 96.6.1 General...................................................................................................................................................................................... 96.6.2 Reused process chemicals ....................................................................................................................................... 9

6.7 Tests of cleaning efficacy ................................................................................................................................................................ 96.7.1 General...................................................................................................................................................................................... 96.7.2 Materials ................................................................................................................................................................................. 96.7.3 Procedure ............................................................................................................................................................................ 106.7.4 Results .................................................................................................................................................................................... 10

6.8 Test of disinfection efficacy ....................................................................................................................................................... 106.8.1 General................................................................................................................................................................................... 106.8.2 Preliminary tests on chemical disinfectants .........................................................................................106.8.3 Self-disinfection tests ................................................................................................................................................116.8.4 Chemical disinfection of the load.................................................................................................................... 12

7 Documentation ....................................................................................................................................................................................................128 Information to be provided by the manufacturer ...........................................................................................................129 Marking, labelling, and packaging ..................................................................................................................................................1310 Information to be requested from the purchaser by the manufacturer ..................................................13Annex A (normative) Summary of test programmes ........................................................................................................................14

© ISO 2016 – All rights reserved iii

Contents Page

ISO 15883-7:2016(E)

Annex B (normative) Methods for microbiological evaluation of disinfection of liquid transport system................................................................................................................................................................................................16

Annex C (normative) Tests for microbiological contamination of post-disinfection rinse water .....21Annex D (normative) Preparation and evaluation of indicators for microbiological testing

oftheefficacyofchemicaldisinfectionoftheload ........................................................................................................22Annex E (informative) Examples of test locations for the tests with biological indicators ......................26Bibliography .............................................................................................................................................................................................................................30

iv © ISO 2016 – All rights reserved

ISO 15883-7:2016(E)

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

ISO 15883-7 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 102, Sterilizers for medical purposes, in collaboration with Technical Committee ISO/TC 198, Sterilization of health care products, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

ISO 15883 consists of the following parts, under the general title Washer-disinfectors:

— Part 1: General requirements, terms and definitions and tests

— Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.

— Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers

— Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes

— Part 5: Test soils and methods for demonstrating cleaning efficacy [Technical Specification]

— Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment

— Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment

© ISO 2016 – All rights reserved v

http://www.iso.org/directives

http://www.iso.org/patents

http://www.iso.org/iso/home/standards_development/resources-for-technical-work/foreword.htm

ISO 15883-7:2016(E)

Introduction

It is intended that this introduction is to be read in conjunction with the introduction to ISO 15883-1.

This part of ISO 15883 is the seventh of a series specifying the performance of washer-disinfectors. It specifies the particular requirements for performance applicable to washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices, and healthcare equipment. Its requirements apply to washer-disinfectors used for cleaning and disinfection of thermolabile equipment for use without further treatment in healthcare settings. Such reusable equipment needs to be cleaned and disinfected, but processing in a washer-disinfector for surgical instruments (see ISO 15883-2), for human waste containers (see ISO 15883-3), for endoscopes (see ISO 15883-4), or for non-invasive, non-critical medical devices, and healthcare equipment employing thermal disinfection (see ISO 15883-6) is inappropriate and/or impractical. Examples of such equipment are bedsteads and bedside furniture, trolleys and transport carts, operating tables, footwear, wheelchairs, or aids for the disabled.

Requirements for washer-disinfectors for other applications are specified in other parts of ISO 15883.

In respect to any potential adverse effects on the quality of water intended for human consumption caused by use of the washer-disinfector, it is noteworthy that

a) until verifiable international criteria are adopted, the existing national regulations concerning the use and/or characteristics of the washer-disinfector remain in force (e.g. the requirement of backflow prevention), and

b) the ISO 15883 series of standards provides no information as to whether the washer-disinfector may be used without restriction in any of the ISO member states.

vi © ISO 2016 – All rights reserved

Washer-disinfectors —

Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment

1 Scope

This part of ISO 15883 specifies the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as the following:

a) bedframes;

b) bedside tables;

c) transport carts;

d) containers;

e) surgical tables;

f) sterilization containers;

g) surgical clogs;

h) wheelchairs, aids for the disabled.

This part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be necessary in order to achieve the required performance.

Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO I5883-4, and ISO 15883-6 do not fall within the scope of this part of ISO 15883.

In addition, the methods are specified, as well as instrumentation and instructions required for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications required to be carried out periodically and after essential repairs.

NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended by the device manufacturer.

The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.

2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

INTERNATIONAL STANDARD ISO 15883-7:2016(E)

© ISO 2016 – All rights reserved 1

ISO 15883-7:2016(E)

ISO 15883-1:2006+A1:2014, Washer-disinfectors — Part 1: General requirements, terms and definitions and tests

ISO 15883-4, Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes

ISO 15883-6, Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment

ISO/TS 15883-5:2005, Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning efficacy

EN 10088-1, Stainless steels — Part 1: List of stainless steels

EN 10088-2, Stainless steels — Part 2: Technical delivery conditions for sheet/plate and strip of corrosion resisting steels for general purposes

IEC 61010-2-040:2005, Safety requirements for electrical equipment for measurement, control and laboratory use — Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

3 Termsanddefinitions

For the purposes of this document, the terms and definitions given in ISO 15883-1, ISO 15883-4, and ISO 15883-6 apply.

4 Performance requirements

4.1 General

4.1.1 The WD shall conform to ISO 15883-1:2006+A1:2014 except for the following subclauses:

— 4.3.1 (which refers to thermal disinfection);

— 5.9 [process temperature control limits, excluding 5.9 d) and e)];

— 5.11 (process verification).

4.1.2 The WD shall be designed to clean and chemically disinfect the range of reusable items specified.

4.1.3 When necessary, the WD shall be provided with means to facilitate the correct alignment of the load in the washing chamber.

4.1.4 The means to control the volume of the process chemical(s) admitted (see ISO 15883-1:2006+A1:2014, 5.7.4 and 5.7.5) shall be adjustable by means of a key, code, or tool. The accuracy of the dosing system shall be at least ±10 % or as specified and tested for conformity (see 6.6).

4.1.5 The automatic controller shall ensure that the final concentration of disinfectants are within the limits specified.

NOTE Confirmation of the concentration of disinfectant can include the measurement of the volume of disinfectant and water admitted together with a certificate of conformity from the disinfectant supplier for the concentration of the disinfectant, together with data to support the shelf life, expiry date, etc.

2 © ISO 2016 – All rights reserved

Documents

Vaskedesinfektorer – Del 7: Krav og prøvninger til ... · Annex ZA’, the user should always check that any referenced document has not been superseded and that ... EN ISO 15883-1:2009